Kornimate/medical-research-clean huggingface dataset:
a long term, post-marketing study of immune response in patients receiving palynziq treatment for pku (palisade)

Conditions: Phenylketonuria (PKU)

Summary: this is a 10-year multi-center, prospective, longitudinal, single arm study evaluating immunologic, inflammatory and laboratory parameters associated with long-term palynziq treatment in subjects with phenylketonuria (pku) in the united states (us). subjects in the us for whom a clinical decision has been made that they will receive pegvaliase to treat their pku within 30 days following the date of enrollment in study 165-501 (incident-users) or who have previously started treatment with pegvaliase at the date of enrollment in study 165-501 (prevalent-users) are eligible for participation in study 165-503.

this is a 10-year multi-center, prospective, longitudinal, single arm study evaluating immunologic, inflammatory and laboratory parameters associated with long-term palynziq treatment in subjects with phenylketonuria (pku) in the united states (us). subjects in the us for whom a clinical decision has been made that they will receive pegvaliase to treat their pku within 30 days following the date of enrollment in study 165-501 (incident-users) or who have previously started treatment with pegvaliase at the date of enrollment in study 165-501 (prevalent-users) are eligible for participation in study 165-503. subjects participating in the 165-501 study who consent to participate in this study (165-503) will be requested to provide pre-dose blood samples for phe, immunologic and inflammatory marker testing approximately every 3 months for the first 3 years of participation, then every 6 months for the remainder of the study. subjects will be requested to provide additional pre-dose blood samples at the time of study 165-501 -protocol defined safety events. additional pre-dose samples will be drawn as per standard of care as detailed in protocol 165-501. the blood phe, immunologic (pal igg, peg igg, peg igm, anti-pegvaliase ige), and inflammatory (c3/c4, hscrp) markers, will be sent to a central laboratory for processing. data collected in the 165-501 study will be combined with the data collected in this study to decrease burden on sites for data entry and to avoid duplication of adr reporting (see criteria for evaluation). the combined data will be reported in the clinical study report for this study. subjects can withdraw from study 165-503 and remain on study 165-501, but they cannot withdraw from study 165-501 and remain on study 165-503 as safety events and other data-points are collected in study 165-501.

Eligibility criteria:
inclusion criteria: * subjects enrolled at us sites participating in the 165-501 study. exclusion criteria: * legal incapacity or limited legal capacity without legal guardian representation. * subject is unable or unwilling to provide informed consent for the additional interventional burden of the study (blood sampling).

Keywords: pku phenylketonuria palynziq pegvaliase observational safety study immunogenicity assessment inflammatory assessment
study of egg-derived influenza vaccine and cell culture-derived influenza vaccine in adult and elderly subjects

Conditions: Influenza, Human

Summary: the purpose of this study is to describe the immunogenicity and safety of the cell culture-derived influenza vaccine compared with the egg-derived influenza vaccine among subjects. to describe the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(hi) assay from sera obtained pre-vaccination and 21 days post-vaccination. to describe the safety, the time of onset and duration of local and systemic solicited adverse events are assessed and reported. unsolicited adverse events and serious adverse events are collected and categorized throughout the study period.

this is a multi-center, randomized, double-blind study in healthy adult and elderly subjects. subjects receive a single dose of one of the influenza vaccine formulations and provide blood samples for immunogenicity assessment.

Eligibility criteria:
inclusion criteria: * healthy adults aged 19 years or older. * the subjects who give written consent to participate in the study voluntarily and are able to comply with all study requirements. * if female and capable of bearing children,subject has a negative urine pregnancy test result on screening and agrees to employ adequate birth control measures through the study period. exclusion criteria: * subjects who are hypersensitive to any component of vaccine, i.e., eggs, chicken or chicken products. * subjects with immune deficiency disorder. * history of guillain-barre syndrome. * thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination. * subjects who experienced fever within 24 hours before vaccination or with the febrile disease(exceeding 38.0℃) on screening day or with any acute respiratory infection. * subjects who had received immunosuppressant or immune-modifying drug within 3 months before screening. * subjects who had received blood products or immunoglobulin within 3 months before screening. * subjects who had received influenza vaccination within 6 months prior to the screening. * subjects who had received other vaccination within a month before screening, or those who had another vaccination scheduled within a month after study vaccination. * subjects who had participated in other clinical trial within 4 weeks prior to study vaccination. * subjects who had done blood donation within a week prior to study vaccination or planned blood donation within 7 months after study vaccination. * subjects with clinically significant chronic disease or malignant cancer. * pregnant women, breast-feeding women. * any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
management of parapneumonic pleurisy guided by an early pleural ultrasound

Conditions: Community-Acquired Infections

Summary: parapneumonic pleurisies are a frequent complication of pneumopathies, but therapeutic management is poorly codified. only the indication of thoracic drainage has benefited from expert recommendations. however, we find in the literature the major importance of early management of infectious pleurisy in order to minimize the sequelae. pleural ultrasound, sensitive and specific in this pathology could bring us a real interest in terms of diagnostic speed and therefore of care. this study therefore seeks to show that pleural ultrasound can have a major interest in improving the management of patients with parapneumonic pleurisy, by reducing the number of medical treatment failures.

this is a prospective, multicentre, non-randomized study evaluating routine care, which includes all patients hospitalized in the departments participating in the study, for pneumonia with or without pleurisy. patients benefiting from a daily pleural ultrasound for 96 hours, d1 being the day of hospitalization. the therapeutic course of action will depend on the presence or not, and on the type of pleural effusion according to a pre-established algorithm. in case of pleural effusion of type 1, the type of treatment will be left to the appreciation of the clinician (puncture or drainage), in case of pleural effusion of type 2, 3 or 4 the patient benefited from pleural drainage. patients included in the study will benefit from a pleural ultrasound on the day of their hospitalization, up to 96 hours after treatment. ultrasound will then allow us to look for the presence of pleural effusion. in the event of effusion corresponding to a parapneumonic effusion or purulent pleurisy, the conduct to be followed will be defined according to the ultrasound type of effusion. types 1 will benefit from an evacuating pleural puncture or drainage, depending on the clinician's judgment. types 2, 3, and 4 will benefit from weeping drainage. the target population: adult patients, hospitalized for pneumonia or confirmed pleurisy, by imaging and exploratory pleural puncture in the departments participating in the study over the period concerned the main outcome measure is the failure of medical treatment, defined as the need to resort to surgery, with or without peeling, or death secondary to pleurisy. the secondary endpoint is the presence of radiological sequelae at 3 months and 6 months defined by a retraction of the hemithorax concerned with pachypleuritis or an ascent of the diaphragmatic dome or the persistence of pleurisy

Eligibility criteria:
inclusion criteria: * adult patients, hospitalized for pneumonia or confirmed pleurisy, by imaging and exploratory pleural puncture. * patients affiliated to social security exclusion criteria: * patients with transudative pleurisy, * patients with exudative pleurisy in the context of pulmonary neoplasia or tuberculosis, * patients with pneumonectomy compartment infections, * patient under guardianship or curatorship, * subjects under 18 years of age, * pregnant women, * patients in emergency situations
vaccination study of abatacept (bms-188667) for normal healthy volunteers

Conditions: Rheumatoid Arthritis

Summary: study to assess the ability of healthy subjects to build anitbodies to tetanus and pneumococcal vaccines after receiving a single intravenous dose of abatacept, a drug which is being developed for the treatment of rheumatoid arthritis and which can affect the immune system.


Eligibility criteria:
inclusion criteria: * healthy subjects * body weight between 60 and 100 kg. * males and females must be using adequate contraceptive methods during study and for 10 weeks after dose of study mediciation. exclusion criteria: * females who are prgnant or breastfeeding * history of autoimmune disorder, immunodeficiency, or infection within past 3 months. * active tb requiring treatment within the previous 3 years. * positive breast cancer screen, ppd test. * vaccination with tetanus or pneumococcal vaccine within 5 years. * vaccination with any live vaccine within 4 weeks. * history of drug or alcohol abuse. * any significant allergy.

Keywords: rheumatoid arthritis
evaluation of breastfeeding success and self-efficacy in mothers giving birth via vaginal delivery or cesarean section

Conditions: Breastfeeding

Summary: this cross-sectional observational study was conducted to compare breastfeeding success and breastfeeding self-efficacy levels of mothers who gave birth via vaginal delivery (spontaneous or via epidural analgesia) or cesarean section (under general or spinal anesthesia).

this study was conducted by including women, who gave birth via vd or cs in the gynecology clinics of a training and research hospital and a city hospital and were in the postpartum period (after 24 hours). it compared the breastfeeding self-efficacy and breastfeeding success of mothers who gave birth via cs (under spinal anesthesia or general anesthesia) with those of mothers who gave birth via vaginal delivery (under epidural analgesia or via spontaneous vaginal delivery).

Eligibility criteria:
inclusion criteria: 1. being aged \>18 years old; 2. being literate; 3. having a baby of weight between 2500-4000 g, with 5th minute apgar score of ≥7, and without congenital diseases and sucking and swallowing problems; 4. not having a disease that prevents breastfeeding; 5. having a full-term (37-42 weeks) vd or cs, 6. agreeing to participate in the study exclusion criteria: 1. a history of psychological or mental health problems 2. any condition in the mother or infant that was a barrier to breastfeeding 3. baby's admission into the neonatal unit 4. baby's separation from the mother for any reason

Keywords: breastfeeding success breastfeeding self-efficacy vaginal delivery cesarean section spinal anesthesia general anesthesia epidural anestezi
a study of tirzepatide (ly3298176) in participants with type 2 diabetes not controlled with diet and exercise alone

Conditions: Type 2 Diabetes Mellitus

Summary: the goal for this study is to evaluate the efficacy and safety of tirzepatide versus placebo in participants with type 2 diabetes not under control with diet and exercise alone. the study will last approximately 47 weeks and may include about 15 visits.


Eligibility criteria:
inclusion criteria: * have been diagnosed with type 2 diabetes mellitus (t2dm). * are naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (oams) during the 3 months preceding screening. * have hba1c between ≥7.0% and ≤9.5%. * be of stable weight (± 5%) for at least 3 months before screening. * have a bmi ≥23 kilograms per meter squared (kg/m²) at screening. exclusion criteria: * have type 1 diabetes mellitus. * have had chronic or acute pancreatitis any time prior to study entry. * have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment. * have disorders associated with slowed emptying of the stomach, or have had any stomach surgeries for the purpose of weight loss. * have an estimated glomerular filtration rate \<30 ml/minute/1.73 m². * have had a heart attack, stroke, or hospitalization for congestive heart failure in the past 2 months. * have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2. * have been taking weight loss drugs, including over-the-counter medications during the last 3 months.

Keywords: glucose-dependent insulinotropic polypeptide (gip) glucagon-like peptide-1 (glp-1) gip/glp-1 dual receptor agonist t2dm
8mm-tips versus endoscopic variceal ligation (evl) plus propranolol for prevention of variceal rebleeding in patients with child a cirrhosis

Conditions: Portal Hypertension

Summary: the aim of this study was to conduct a prospective randomized trial to compare tips with 8mm expanded polytetrafluoroethylene(eptfe)-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding in patients with child a cirrhosis

for the prevention of recurrent esophageal variceal bleeding, previous clinical studies and meta-analysis show that patients treated with transjugular intrahepatic portosystemic shunt (tips) have lower rebleeding rates compared with endoscopic therapy. however, tips is associated with higher rates of portosystemic encephalopathy and does not show survival benefit. tips with a small-diameter may achieve sufficient portal decompression and reduce the incidence of hepatic encephalopathy. the aim of this study was to conduct a prospective randomized trial to compare tips with 8mm eptfe-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.

Eligibility criteria:
inclusion criteria: cirrhosis patients who had bled from esophageal varices (≥5days and ≤28days) child-pugh a - exclusion criteria: the presence of gastric varices non-cirrhotic portal hypertension portal vein thrombosis the history of hepatic encephalopathy total bilirubin ≥51.3 umol/l previous treatment of tips or surgery proven malignancy including hepatocellular carcinoma contraindications to tips、evl or propranolol end-stage renal disease under renal replacement therapy; cardiorespiratory failure pregnancy or patients not giving informed consent for endoscopic procedure -
functional outcome comparison of implant-free bone-patellar tendon autograft in arthroscopic acl reconstruction

Conditions: Anterior Cruciate Ligament Injuries; Ligament; Rupture, Knee, Spontaneous; Tendon Graft; Complication, Mechanical

Summary: the use of implants for conventional anterior cruciate ligament (acl) graft fixation has been associated with several problems including graft injury, implant osteolysis, implant migration and soft tissue irritation. implantless acl surgery offers additional benefits involving lower cost, improved graft incorporation and ease of revision surgery. the investigators aimed to compare the functional outcome of implantless bone-patellar tendon autograft using press-fit fixation technique and hamstring autografts using implant.

purpose: the use of implants for conventional anterior cruciate ligament (acl) graft fixation has been associated with several problems including graft injury, implant osteolysis, implant migration and soft tissue irritation. implantless acl surgery offers additional benefits involving lower cost, improved graft incorporation and ease of revision surgery. the investigators aimed to compare the functional outcome of implantless bone-patellar tendon autograft using press-fit fixation technique and hamstring autografts using implant. materials and methods: a prospective cohort study design was used. between march 2013 and march 2014, 12 patients underwent implantless acl reconstruction using press-fit femoral technique, while 24 patients underwent implant acl reconstruction. objective functional outcome were measured using rolimeter, and subjective functional outcome were measured according to ikdc, tegner-lysholm and koos.

Eligibility criteria:
inclusion criteria: * total rupture of acl on a single knee exclusion criteria: * increased knee laxity according to beighton hypermobility score * previous history of knee surgery

Keywords: anterior cruciate ligament anterior cruciate ligament injury implantless acl reconstruction press-fit fixation
dental dyschromia and quality of life in early prolonged hyperbilirubinemia

Conditions: Dental Diseases

Summary: the main objective of this study is to assess the prevalence of dental discoloration (dental dyschromia) in children who experienced high levels of bilirubin in their blood (hyperbilirubinemia) during their early years. the study will also examine risk factors associated with this condition, such as the duration and severity of hyperbilirubinemia, underlying diseases, and treatments received. the researchers hypothesize that the quality of life of individuals with dental dyschromia is lower than that of individuals without dyschromia. the results of this study will be used to discuss coverage for dental care with health insurance for children affected by this condition.


Eligibility criteria:
inclusion criteria: * a patient with biliary atresia, progressive familial intrahepatic cholestasis, or alagille syndrome * patient or legal representative not opposed to participating in this research. exclusion criteria: * inability to understand and respond to quality of life questionnaires

Keywords: hyperbilirubinemia biliary atresia progressive familial intrahepatic cholestasis (pfic) alagille syndrome tooth discoloration
transitioning care: perspectives of older women with early breast cancer on current telemedicine modalities

Conditions: Breast Cancer Female; Breast Cancer

Summary: explosive growth in the use of telemedicine (video or telephone visits) has followed the onset of the coronavirus disease 2019 (covid-19) pandemic in order to meet healthcare needs while avoiding unnecessary exposure risks in ambulatory care spaces. accordingly, in march 2020, the centers for medicare \& medicaid services expanded reimbursement for telemedicine visits to equal that of in-person services. the policy and infrastructure that enabled this emergency transition is laying the groundwork for enduring expansion of elective telemedicine, a technology that could significantly decrease the burden of medical care in older patients with cancer. to benefit from telehealth, patients must have a certain level of knowledge and capacity to engage with technology, which can be a challenge for some older adults because of inexperience, access, and disability. as cancer is mainly a disease of older adults, with a median age of 65 at diagnosis for most cancer types, this is a significant limitation on the utility of telemedicine in oncology. the goal of our study is to better understand older breast cancer patients' experiences with telephone and video telemedicine with regard to visit convenience, completeness, and interpersonal satisfaction through semi-structured interviews with patients.

methods: 30 participants will be consented in this study. 20 will have participated in video telemedicine appointments with their treating breast cancer oncologists, and 10 will have used telephone. semi-structured interviews lasting no more than 30 minutes will be conducted to ascertain the participant's (1) reason for choosing a certain telemedicine modality, (2) perception of telemedicine visit convenience, completeness, and interpersonal satisfaction compared to in-person visits, and (3) use of peripheral virtual support from healthcare team, such as messaging in mychart. after the interview has been conducted, the patient will be asked complete the patient-reported portion of the geriatric assessment (ga) either through an internet link, or verbally with the research staff reading the questions and recording the answers. data pertaining to the participant's breast cancer diagnosis and treatment will be extracted from epic@unc.

Eligibility criteria:
inclusion criteria: * female * age 65 or older * diagnosed with early breast cancer (stage i-iii) * completed primary treatment (surgery, chemotherapy, radiation treatment) * received in-person outpatient care at north caroline cancer hospital before transitioning to telemedicine after march 2020 * providing written informed consent * able to understand and speak english. exclusion criteria: * patients who do not meet the inclusion criteria stated above will be excluded. there will be no further exclusion criteria.

Keywords: telemedicine
the efficacy of silymarin as adjuvant therapy on colorectal cancer patients undergoing folfiri treatment

Conditions: Metastatic Colorectal Cancer

Summary: primary objectives: use both listed and relatively safe drug, silymarin,s to improve the intestinal side effect of the patients undergoing folfiri chemotherapy.

primary objective: use both listed and relatively safe drug, silymarin, to improve the intestinal side effect of the patients undergoing folfiri chemotherapy. patient selection and enrollment: number of subjects: eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach approximately 70 patients in total. plan of the study: study design this is an open-label, randomized, comparative, double arm, single center study to assess efficacy of silymarin as adjuvant therapy on metastatic colorectal cancer patients undergoing folfiri chemotherapy in taiwan. subject number eligible patients will be randomized in 2 arms in the ratio of 1:1, to reach approximately 70 patients in total. study schedule study date: the time getting approval letter issued by both regulatory authority and institutional review board (irb) duration of study: from the date of the irb was approved till the 70th patient was collected. duration of enrollment: from the date of the irb was approved till the 70th patient was collected. duration of treatment: from the 1st patient starting chemotherapy till the 70th patient finishing the 6th cycle chemotherapy. duration of follow-up: from the 1st patient starting chemotherapy till 3 months after the 70th patient finishing the 6th cycle chemotherapy

Eligibility criteria:
inclusion criteria: 1. the patient who is between 20 to 80 years old 2. the patient who is diagnosed metastatic colorectal cancer and received chemotherapy with folfiri regimen 3. the female patient should not be pregnant or breast-feeding 4. the patient who has no severe co-morbidity, such as cardiovascular, cerebrovascular, malignant hypertension, renal and hepatobiliary disease. 5. the patient who has no associated drug allergy to this trial. 6. the patient who is in compliance with prescribed medication. 7. the patient who is willing to sign the permit of the clinical trial. exclusion criteria: 1. the patients who do not meet the main inclusion criteria or are not willing to sign the permit. 2. the patient who has viral hepatitis or carrier with impaired liver function.

Keywords: cpt-11(irinotecan) silymarin gi toxicity